The Ivy Brain Tumor Center at Barrow Neurological Institute is conducting a Phase 2 study of sonodynamic therapy (SDT) in patients with recurrent glioblastoma (rGBM).
The primary objectives of this nonsurgical study are to evaluate the safety and preliminary efficacy of SDT using SONALA-001 (ALA) and Exablate Type-2 device in patients with recurrent or progressive GBM.
Oral ALA is a drug currently used in patients with certain types of tumors to assist in tumor visualization and increase the amount of tumor resected during surgery. In this study, we will investigate the drug’s ability to make the tumor tissue more sensitive to ultrasound, ultimately slowing tumor growth.
Criteria:
- You are 18 years or older.
- You have a histologically diagnosed primary glioblastoma that has recurred or progressed, and resection is not indicated.
- You received previous first-line treatment with standard-of-care radiotherapy and temozolomide. Temozolomide is only required if the tumor has at least partial methylation of the MGMT promoter.